Kornimate/medical-research-clean huggingface dataset:
exploratory study on the paclitaxel + s-1 + oxaliplatin (psox) for locally advanced or advanced gastric cancer

Conditions: Gastric Cancer

Summary: explore the efficiency and safety of paclitaxel + s-1 + oxaliplatin (psox) chemotherapy in the patients with locally advanced or advanced gastric cancer

to assess the efficiency and safety of paclitaxel + s-1 + oxaliplatin(psox) in the patients with locally advanced or advanced gastric cancer

Eligibility criteria:
inclusion criteria: 1. histopathology or cytopathology proven gastric cancer or gastroesophageal adenocarcinoma; 2. locally advanced, or recurrent, or metastasis disease； 3. chemotherapy-naive or disease progress at least 6 months after adjuvant chemotherapy completed; 4. life expectancy of at least 3 months; 5. ecog score 0-1; 6. age: 18\~70 years old; 7. normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). for example: wbc\>4.0×109/l, neu \>1.5×109/l, plt\>100×109/l, bil\<1.5 times of upper limit of normal reference value, alt and ast\<2.5 times of upper limit of normal reference value, and cre\<1.2mg/dl; 8. good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases; 9. not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver); 10. not participating in other study projects before and during the treatment; 11. voluntarily signed the informed consent. exclusion criteria: 1. previously treated with first-line chemotherapy; 2. allergy to the drugs in this protocol; 3. pregnant or lactating women; 4. women at childbearing age and of pregnancy desire during the study.

Keywords: paclitaxel s-1 oxaliplatin efficiency safety
a clinical trial to evaluate the safety and efficacy of traditional chinese medicine in sjögren's syndrome.

Conditions: Sjögren's Syndrome

Summary: to investigate the efficacy and safety of traditional chinese medicine in patients with sjogren's syndrome.

this is 2 years' double blind, randomized, placebo-controlled clinical trial. patients fulfilled the classification criteria of sjogren syndrome will be recruited. eligible subjects will be randomized on a 2:1 ratio to traditional chinese medicine (tcm) granules or placebo for 12 weeks. the treatment group will receive a combination formula with traditional chinese medicine, gan-lu-yin in the morning and jia-wei-xiao-yao-san in the evening. primary endpoint is the esspri, european sjogren syndrome patient reported outcome index. secondary endpoints include disease activity index (essdai) , patient global assessment (pga), vas pain scale, quality of life by short form-36 (sf-36), fatigue scale and related serological markers. thirty patients will be enrolled in the first year. after interim analysis at the end of first year, sample size will be recalculated base on the interim analysis results.

Eligibility criteria:
inclusion criteria: * age ≥20 years old * written informed consent obtained * been diagnosed with the diagnostic criteria for sjogren's syndrome (according to the 2002 european classification standard) * the esspri score of the patient of sjogren's syndrome at least\> 3 exclusion criteria: * have association disease about heart, lung, nerve or mental * pregnant or breastfeeding women * laboratory abnormality: 1. serum creatinine ≥2.0 mg/dl 2. male: hb≤9 g/dl;female: hb≤8.5 g/dl 3. neutrophil or lymphocyte\<0.5 x 109/l

Keywords: sjögren's syndrome traditional chinese medicine herbs clinical trial gan-lu-yin jia-wei-xiao-yao-san ye-jiao-teng suan-zao-ren
beyond tme origins

Conditions: Neoplasms; Adenocarcinoma; Carcinoma

Summary: all patients with recurrent colorectal cancer in the pelvis are eligible. the original primary tumour staging scans and resected surgical specimen needs to be available. patients' recurrence will be staged using our proposed mri classification. we will be assessing the original primary staging scans and histopathology to learn about risk factors for recurrence. we will record treatment for the recurrence, and patients will be followed up for three years.

a prospective and retrospective cohort study to improve surgical and treatment planning using an imaging assessment proforma of advanced and recurrent colorectal cancers. this involves the implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.

Eligibility criteria:
inclusion criteria: 1. had a primary colorectal adenocarcinoma proven by biopsy taken as part of routine clinical practice 2. has a confirmed diagnosis of recurrent pelvic colorectal cancer 3. has previously completed surgical treatment of primary adenocarcinoma of the colon, sigmoid colon or rectum 4. are able to undergo high resolution mri for staging prior to treatment decisions 5. have provided written informed consent to participate in the study 6. be aged 16 years or over exclusion criteria: 1. have irresectable extra-pelvic metastatic disease 2. original baseline staging and preoperative restaging scans (mr for rectal and sigmoid cancers and/or ct for colon and sigmoid cancers) are unavailable 3. original preoperative, surgical and adjuvant treatment has not been documented or is unavailable

Keywords: lower gastrointestinal tract rectum diagnostic imaging magnetic resonance imaging pelvic exenteration neoplasms adenocarcinoma carcinoma
assessment of pelvic floor strength variables in female nulliparous athletes

Conditions: Pelvic Floor Muscle Weakness; Strength; Muscle Tone

Summary: functional fitness training (fft) is a modality that seeks to improve physical fitness and performance within several functional tasks by conducting a variety of training activities such as aerobic and metabolic conditioning, resistance training, and high impact exercises. although there are many benefits of fft for improving fitness and body composition, their effects on the pelvic floor are not clear, as high-impact exercises performed in fft have been shown to cause an increase in intra-abdominal pressure. when these exercises are performed repeatedly, fatigue can occur within the pelvic floor muscles (pfm), which can increase the risk of developing pelvic floor dysfunctions. however, currently little is known about how fft activities acutely affect the pfm and whether such training regimes may contribute to long-term urinary incontinence in female fft athletes. therefore, this study aimed to analyse the acute effects of a fft.workout on pelvic floor strength and muscle activation in nulliparous female fft athletes. it is hypothesized that both strength and pfm activation of the female athletes would be reduced after a fft workout due to pfm fatigue.


Eligibility criteria:
inclusion criteria: * nulliparous * have been practicing fft or weightlifting for at least 2 years * train a minimum of 3 days/week that did not include pelvic floor exercises * have no medical contraindications or previous pelvic floor surgeries exclusion criteria: * any criterion that fails to meet the inclusion criteria
polyhexamethylene biguanide increases the regression rate of human papillomavirus (hpv) infection

Conditions: HPV Infection

Summary: human papillomavirus (hpv) infection is a worldwide problem strictly linked to the development of cervical cancer. persistence of the infection is one of the main factors responsible for the invasive progression and women diagnosed with intraepithelial squamous lesions are referred for further assessment and surgical treatments which are prone to complications. despite this, there are several reports on the spontaneous regression of the infection. in this study the investigators will evaluate the effectiveness of a long term polyhexamethylene biguanide (phmb)-based local treatment in improve the viral clearance reducing the time exposure to the infection and avoiding the complications associated with the invasive treatments currently available. women diagnosed with hpv infection were randomly assigned to receive six months of treatment with a phmb-based gynaecological solution (monogin®) or to remain untreated for the same period of time. the administration of monogin® has been performed every three days for fifteen days and then every fifteen days for the subsequent six months.


Eligibility criteria:
inclusion criteria: * pathologic pap smear * positive "high risk" hpv dna test * positive colposcopy examination exclusion criteria: * patients who had undergone wart therapy in the previous six months * pregnancy * invasive disease * immunosuppression * previous hpv vaccination

Keywords: hpv polyhexamethylene biguanide intraepithelial lesions regression rate
evaluation of new feedback canceller for carina™ implant

Conditions: Hearing Loss

Summary: the purpose of this study is to evaluate audio quality benefit for the patient implanted with a cochlear or otologics carina implant with the new firmware (feedback canceller algorithm) whatever the patient environment is and to evaluate the functional gain and speech understanding benefit for the patient upon the firmware used (new and reference firmware). the new firmware aims to adapt automatically for feedback cancellation without prior calibration.


Eligibility criteria:
inclusion criteria: * successfully implanted with a commercial available ce-labelled implant device, resulting in measurable open set speech understanding * native speaker in the language used to assess their clinical performance, i.e. french exclusion criteria: * unwillingness or inability to comply with all of the investigational requirements * additional handicaps that would prevent or restrict participation in the audiological evaluations

Keywords: middle ear implant feedback manager sound quality
radiation stent versus self-expanding metallic stents (sems) for palliative treatment of malignant biliary stricture

Conditions: Cholangiocellular Carcinoma; Pancreatic Cancer; Gallbladder Cancer; Metastatic Carcinoma

Summary: malignant biliary obstruction is a common clinical condition caused by various malignancies. currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the most important methods for relieving malignant biliary obstruction. however, the benefit for the survival of the patients with palliation of the stent treatment is limited because no therapeutic effects on process of the tumor itself by a stent implantation. encouraged by the success of 125i esophageal stent in esophageal carcinoma, a novel biliary stent loaded with 125i radioactive seeds has been developed in our institute. after ex vivo and in vivo evaluations for the delivery system, the investigators prospectively compare the responses to treatment with this radiation biliary stent, versus the conventional biliary sems in patient with malignant biliary obstruction.


Eligibility criteria:
inclusion criteria: * age 18 years old or older * biliary obstruction by any malignant process with histologically or cytologically confirmed by biopsy or previous surgical procedures * clinical symptoms of biliary obstruction * unresectable or refused to be surgically treated biliary obstruction by any malignant process * willing and able to comply with the study procedures and provide written informed consent to participate in the study exclusion criteria: * suspected benign bile duct stricture * strictures that can not be dilated enough to pass the delivery system * perforation of any duct within the biliary tree * presence metallic biliary stent or bile duct surgery * patients for whom ptc procedures are contraindicated * patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver * noncooperation or no authorization and signature
exercise intervention prior to crs-hipec: feasibility & impact

Conditions: Colon Cancer; Ovarian Cancer; GI Cancer; Gynecologic Cancer

Summary: our objective is to initiate an exercise program for patients with advanced gi or gyn cancer, as prehabilitation prior to surgery. the objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. the prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (crs) and heated intraperitoneal chemotherapy (hipec)

our objective is to assess the feasibility and impact of implementing an exercise program for patients with advanced gi or gyn cancer, as prehabilitation prior to surgery. the objective of the prehabilitation program is to reduce complication rates and improve the length and quality of survival for patients with abdominal cancer. the prehabilitation program will be offered to patients who are eligible for and consent to cytoreductive surgery (crs) and heated intraperitoneal chemotherapy (hipec).

Eligibility criteria:
inclusion criteria: * patients with peritoneal metastasis from appendix, colon, small bowel, endometrium, ovary or any other gi or gyn primary tumor * patients should be eligible for and consent to surgery with the intention of performing crs / hipec at penn state hershey medical center. eligibility for crs/hipec is a clinical determination based on a combination of factors including radiographic extent of disease, tumor histology and medical fitness for surgery * subjects who are explored but found to be unresectable will be included. * male or female. * patients should be age 18 or above. * surgery is planned for not less than 6 weeks and no more than 10 weeks from consultation exclusion criteria: * patients who do not consent to surgery. * patients who require urgent surgery, sooner than 6 weeks * patients receiving neoadjuvant chemotherapy, with no surgical date planned before 10 weeks from consultation. these patients can be enrolled at the time of the follow-up visit, as long as they meet above criteria * patients not fluent in english * pregnant women * prisoners * patients with cognitive impairment

Keywords: hipec crs prehabilitation exercise
stereotactic ablative radiotherapy for comprehensive treatment of 4-10 oligometastatic tumors

Conditions: Metastatic Tumors

Summary: in patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. the application of stereotactic ablative radiotherapy (sabr) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved overall survival (os), progression free survival (pfs), or quality of life. the purpose of this study is to assess the impact of sabr, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.


Eligibility criteria:
inclusion criteria: * age 18 or older * willing to provide informed consent * karnofsky performance score greater than 60 * life expectancy greater than 6 months * histologically confirmed malignancy with metastatic disease detected on imaging. biopsy of metastasis is preferred, but not required. * controlled primary tumor defined as: at least 3 months since original tumor treated definitively, with no progression at primary site * total number of metastases 4-10 * all sites of disease can be safely treated based on a pre-plan exclusion criteria: * serious medical comorbidities precluding radiotherapy. these include interstitial lung disease in patients requiring thoracic radiation, crohn's disease in patients where the gi tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma. * for patients with liver metastases, moderate/severe liver dysfunction (child pugh b or c) * substantial overlap with a previously treated radiation volume. prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. for patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. all such cases must be discussed with one of the study pis. * malignant pleural effusion * inability to treat all sites of disease * any single metastasis greater than 5 cm in size. * any brain metastasis greater than 3 cm in size or a total volume of brain metastases greater than 30 cc. * metastasis in the brainstem * clinical or radiologic evidence of spinal cord compression * dominant brain metastasis requiring surgical decompression * metastatic disease that invades any of the following: gi tract (including esophagus, stomach, small or large bowel), mesenteric lymph nodes, or skin * pregnant or lactating women
clinical outcomes after implantation of a monofocal hydrophobic iol, bi-flex 877pay with pob-ma preloaded injector

Conditions: Cataract

Summary: the purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing pco (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal iol, bi-flex 877pay (medicontur).

the purpose of our investigation is to retrospectively assess visual outcomes, refractive stability, safety features of the lens and the incidence of developing pco (posterior capsular opacification) in a 12-month period following mono- or bilateral implantation of the hydrophobic acrylic monofocal iol, bi-flex 877pay (medicontur). * primary objective: o to evaluate the monocular uncorrected distance visual acuity (ucdva) 1 year after iol implantation * secondary objectives: * to evaluate the spherical equivalent refraction one month postoperatively. * to evaluate level of astigmatism one month postoperatively. * to evaluate the uncorrected distance visual acuity (udva) monocular at 1 day, 1 month and 6 months after iol implantation * to evaluate the best corrected distance visual acuity (cdva) monocular at 1 month, 6 months and 1 year after iol implantation * to evaluate safety features of the lens * to evaluate pco development, nd:yag capsulotomy rate

Eligibility criteria:
inclusion criteria: 1. male or female patients who underwent cataract surgery in one or both eyes and who were implanted with bi-flex 877pay iol mono- or bilaterally. 2. patients with regular post-operative visits over 12 months period after surgery. 3. patients of any age above 18 years and any medical history who are eligible according the investigator's decision. exclusion criteria: 1. preoperative corneal astigmatism \> 1.5 d 2. uncontrolled diabetic retinopathy 3. iris neovascularisation 4. serious intraoperative complications
a study of ak112 for advanced solid tumors

Conditions: Solid Tumor, Adult

Summary: this study is to characterize the safety, tolerability, pharmacokinetics (pk), immunogenicity, pharmacodynamics (pd) and anti-tumor activity of ak112, a pd-1/vegf bispecific antibody, as a single agent in adult subjects with advanced solid tumor malignancies. this trial is a two parts, phase i/ii study. all patients are advanced solid tumor, eastern cooperative oncology group (ecog) performance status 0-1. part one is dose escalation phase,part two is dose expansion phase. the primary end point is safety. secondary end points are objective response rate,progression-free survival and overall survival per recist1.1.


Eligibility criteria:
inclusion criteria: * aged 18 to 75 years old (at the time consent is obtained); * be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures); * have histologically- or cytologically-confirmed diagnosis of advanced solid tumor; * available archived tumor tissue sample to allow for correlative biomarker studies. in the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy; * eastern cooperative oncology group (ecog) performance score of 0 or * subject must have at least one measurable lesion according to recist version1.1; * adequate organ function; * females of childbearing potential and non-sterilized males who are sexually active must use an effective method; * adequate life expectancy. exclusion criteria: * history of severe hypersensitivity reactions to other mabs; * unresolved toxicities from prior anticancer therapy, defined as having not resolved to nci ctcae v5.0 grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria; * major surgical procedure within 30 days prior to the first dose of ak112 or still recovering from prior surgery; * receipt of any immunotherapy, any conventional or investigational systemic anticancer therapy within 4 weeks prior to the first dose of ak112 except for treatment with small-molecule tyrosine kinase-targeted agents within 2 weeks prior to the first dose of ak112; * history of primary immunodeficiency; * active or prior documented inflammatory bowel disease (eg, crohn's disease, ulcerative colitis); * history of organ transplant or hematopoietic stem cell that requires use of immunosuppressives; * known allergy or reaction to any component of the ak112 formulation; * history of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies; * known history of tuberculosis; * known history of hiv; * receipt of live attenuated vaccination within 30 days prior to the first dose of ak112; * any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
ventilator associated pneumonia care bundle prevention on internship students' knowledge and clinical performance

Conditions: Ventilator Associated Pneumonia

Summary: the goal of this clinical trial is to determine the effect of a self-instructional module regarding ventilator-associated pneumonia care bundle prevention on internship students' knowledge and clinical performance in pediatric intensive care unit.the hypotheses of this study were as follows: 1. internship students who are taught by vap care bundle prevention self-instructional module exhibit higher scores in knowledge test about vap care bundle prevention than those who are not. 2. internship students who are taught by vap care bundle prevention self-instructional module exhibit higher scores in performing the vap care bundle prevention procedure than those who are not. 3. internship students who are taught by vap care bundle prevention self-instructional module exhibit more positive feedback about it than those who are not.


Eligibility criteria:
inclusion criteria: * nursing intern students at faculty of nursing, alexandria university, egypt. exclusion criteria: * no

Keywords: self-instructional module ventilator associated pneumonia care bundle prevention internship students knowledge clinical performance pediatric intensive care unit